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The Ultimate Quality Management Validation Specialist Job: Join Thermo Fisher Scientific in Lengnau, Switzerland!

Quality Management Specialist Job Openings at Thermo Fisher Scientific

Quality Management Specialist Job Openings at Thermo Fisher Scientific Company. Interested Candidates Can check out the details below and Apply.

Job Position: Quality Management Validation Specialist

Company: Thermo Fisher Scientific

Job Location: Lengnau, Berne, Switzerland

As a Quality Management Validation Specialist, you are part of the Quality Management team at our new Lengnau facility. Your core responsibility lies in the compliance checks for validation documents and Master Batch records.

During ramp up of the facility, the role plays a key part in ensuring Quality oversight of validation activities and provide QA support and mentorship to related functional departments.

Your Responsibilities

  • Ensure compliance to Quality Standards and Validation Master Plans for Cleaning- and Manufacturing Processes working closely with MSAT, QC, Manufacturing and Engineering teams.
  • Actively assess change and deviations associated to cleaning and process validation as well as analytical method validation.
  • Ensure that electronic Master Batch Records are established and in line with Validation Reports and are compliant to internal standards and to cGMP regulatory expectations.
  • Improve continuously quality standards for assigned areas of responsibilities.
  • Actively support regulatory inspections as well as customer audits.

Qualification:

  • Degree (Bachelor or Masters) in Life Sciences (Biology, Chemistry, etc.) or Engineering, Dipl. lng. or M.Sc. or B.Sc. or equivalent.
  • Experience (minimum 3 years) preferably gained on a Life Sciences / Pharma / Biotech (Upstream / Downstream / Fill Finish) manufacturing facility.
  • Knowledge in chemical, biotech, or pharmaceutical manufacturing process as well as fundamental knowledge in the basics of cleaning and/or process validation.
  • Basic Understanding of cGMP, GLP & cGxP practices.
  • Experience (2 years minimum) in one of the relevant areas: Master Batch record review in an electronic Manufacturing Execution System (MES), Validation of Cleaning and / or Manufacturing Processes and / or Analytical Methods.
  • Proficient communication (oral and written) in English and German.

APPLY HERE

Shekhar
Shekhar
Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.
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